1. Field of the Invention
The present invention generally relates to a system and method for controlled delivery of substances and more particularly to controlled infusion of test substances to a test subject.
2. Description of Related Art
The pharmaceutical industry, contract research organizations, academia, and government entities routinely test the efficacy and safety of new chemical entities using intravenous infusion in laboratory animals such as, rats, dogs, and certain nonhuman primates. In some cases, large-scale toxicology infusion studies that can be used to assess the safety of new chemical entities are performed on a number of subjects. For instance, studies may assess several hundred animals for extended periods of time (e.g., many months or more). In other cases, drug metabolism, pharmacology, or safety pharmacology studies are performed using fewer animals over shorter periods.
These studies and other veterinary and/or human medical and research applications may include the use of medical and laboratory infusion pumps (e.g., electromechanical infusion pumps and other pumps). Infusion pumps may include, for instance, numerous types of electromechanical infusion pumps such as syringe, piston, peristaltic, diaphragm, large volume, stationary (“pole mount”), and portable (“ambulatory”) type pumps. Other infusion pumps utilize gravity, springs, pneumatics, hydraulics, gases and other means. These pumps may be used to deliver a fluid (e.g., a new chemical entity) at a controlled delivery rate to a laboratory test animal, for instance. Similar pump technologies may be used for laboratory animal infusion and human-use infusion. Often, methods for human-use infusion (e.g., in a healthcare application) may be tailored to a single patient's needs while laboratory animal infusion (e.g., in an industrial or research application) may include common parameters tailored for use with multiple animals.
During studies, test substances may be delivered to a test subject, such as a laboratory animal, via a fluid delivery system conduit. For example, the test subject may be connected to an infusion pump (e.g., a syringe pump) using a network of components to carry the fluid from a pump fluid reservoir (e.g., a syringe) to the test subject. The network of fluid-carrying components, which may be referred to as “tubing set”, may include various combinations of catheter, needle, cannula, polymeric tubing, fluid swivel, luer connectors, stopcocks, metal tubing for connecting polymer tubing, air filters, particle filters, etc. During use, the steps of loading, unloading, programming, starting and stopping one or more pumps, and adding or removing fluid delivery conduit systems are typically performed manually. For example, operators may manually enter one or more delivery rates into a pump, load a fluid-filled syringe into the pump, start fluid delivery from the pump by pressing a start button on the pump, and stop the pump by pressing a stop button. Further, users may manually document, using pen and paper or using a computer according to Good Laboratory Practices (GLP's), all these steps, as typically required by regulatory bodies, such as the Unites States Food and Drug Administration (FDA). The recorded data may include the type of fluid solution delivered by a pump, a user name, a time and date of each step, and description of the cause and/or resolution of pump alarms (e.g., occlusion alarms, syringe empty alarms, and other alarms indicating adverse pumping conditions). These steps may be complex, time consuming, labor intensive (e.g., requiring many operator man-hours), and increase the likelihood of human error. Additionally, these steps may provide undesirable contact between an operator and a test subject. For example, undesirable contact may occur in the case of containment (e.g., of allergens, disease, and other contamination), need for reduction of stimulation of test subject (e.g., the study of physiological parameters including heart rate and blood pressure), and other cases.
Accordingly, it may be desirable to provide a technique (e.g., system and/or method) that reduces the complexity of delivering test substances to a test subject. It may be desirable to provide techniques suitable for automating certain aspects of the toxicologic infusion study processes. Automating certain aspects of the processes may reduce the man-hours required for infusion studies, improve the quality of infusion studies by reducing the likelihood of human error, and/or reduce operator contact with test subjects.